Medicines, Poisons and Therapeutic Goods Regulation 2008
6Overview of things to which medicines and poisons
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6 Overview of things to which medicines and poisons standard does not apply (1) The medicines and poisons standard applies to regulated substances (see the Act, pt 3.1 and s 17). (2) However, the medicines and poisons standard sets out the following things to which it does not apply (unless there is a contrary intention in the standard): (a) a substance in a preparation or product included in the standard, appendix A; (b) a substance and the reason for its entry in the standard, appendix B; (c) a substance to which the standard, appendix G applies; (d) certain low concentrations of substances included in the standard, schedules 1 to 6 if the substance is not also included in schedule 7 or 8; (e) certain impurities in pesticides.
Chapter 2 Medicines—authorisations Part 2.1 Overview of medicines 10 General overview of authorisations for medicines (1) The Act requires that a person must not deal with a medicine in a particular way unless the person is authorised to deal with the the Act, s 35 is about obtaining certain substances (which include medicines) Note The Act, s 19 sets out when a person deals with a medicine. (2) The Act, section 20 sets out when a person is authorised to deal with a medicine. (3) This regulation authorises certain dealings with medicines. Note An authorisation is not required to deal with the following: • a substance excluded from the medicines and poisons standard by the standard; • a substance mentioned in the medicines and poisons standard, sch 2, 3, 4 or 8 if none of the schedules apply to the substance because of an exception in the standard (eg Aspirin in packets available from supermarkets). (4) An authorisation under this regulation may be subject to limitations. Examples—s (4) 1 a health practitioner’s authorisation is subject to any condition or restriction to which the health practitioner is subject to under the Health Practitioner Regulation National Law (ACT) (see s 20) 2 the authorisation of a person to prescribe a medicine is subject to any restriction included in sch 1 in relation to the person (see s 30 (1) (b)) Note For the power to impose other restrictions, see the Act, ch 8.